[Federal Register Volume 59, Number 218 (Monday, November 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28023]


[[Page Unknown]]

[Federal Register: November 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[BPO-127-N]

 

Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances and Coverage Decisions--Second Quarter 1994

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Notice.

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SUMMARY: This notice lists HCFA manual instructions, substantive and 
interpretive regulations and other Federal Register notices, and 
statements of policy that were published during April, May, and June of 
1994 that relate to the Medicare and Medicaid programs. Section 1871(c) 
of the Social Security Act requires that we publish a list of Medicare 
issuances in the Federal Register at least every 3 months. Although we 
are not mandated to do so by statute, for the sake of completeness of 
the listing, we are including all Medicaid issuances and Medicare and 
Medicaid substantive and interpretive regulations (proposed and final) 
published during this timeframe.
    We are also providing the content of revisions to the Medicare 
Coverage Issues Manual published between April 1 and June 30, 1994. On 
August 21, 1989, we published the content of the Manual (54 FR 34555) 
and indicated that we will publish quarterly any updates. Adding to 
this listing the complete text of the changes to the Medicare Coverage 
Issues Manual allows us to fulfill this requirement in a manner that 
facilitates identification of coverage and other changes in our 
manuals.

FOR FURTHER INFORMATION CONTACT:

Margaret Cotton, (410) 966-5255 (For Medicare instruction information)
Walter Rutemueller, (410) 966-5395 (For Medicare coverage information)
Pat Prete, (410) 966-3246 (For Medicaid instruction information)
Michael Robinson, (410) 966-5633 (For all other information)

SUPPLEMENTARY INFORMATION:

I. Program Issuances

    The Health Care Financing Administration (HCFA) is responsible for 
administering the Medicare and Medicaid programs, which pay for health 
care and related services for 36 million Medicare beneficiaries and 33 
million Medicaid recipients. Administration of these programs involves 
(1) Providing information to Medicare beneficiaries and Medicaid 
recipients, health care providers, and the public; and (2) effective 
communications with regional offices, State governments, State Medicaid 
Agencies, State Survey Agencies, various providers of health care, 
fiscal intermediaries and carriers who process claims and pay bills, 
and others. To implement the various statutes on which the programs are 
based, we issue regulations under authority granted the Secretary under 
sections 1102, l871, and 1902 and related provisions of the Social 
Security Act (the Act) and also issue various manuals, memoranda, and 
statements necessary to administer the programs efficiently.
    Section 1871(c)(1) of the Act requires that we publish in the 
Federal Register at least every 3 months a list of all Medicare manual 
instructions, interpretive rules, statements of policy, and guidelines 
of general applicability not issued as regulations. We published our 
first notice June 9, 1988 (53 FR 21730). Although we are not mandated 
to do so by statute, for the sake of completeness of the listing of 
operational and policy statements, we are continuing our practice of 
including Medicare substantive and interpretive regulations (proposed 
and final) published during the 3-month timeframe. Since the 
publication of our quarterly listing on June 12, 1992 (57 FR 24797), we 
decided to add Medicaid issuances to our quarterly listings. 
Accordingly, we are listing in this notice Medicaid issuances and 
Medicaid substantive and interpretive regulations published from April 
1 through June 30, 1994.

II. Medicare Coverage Issues

    We receive numerous inquiries from the general public about whether 
specific items or services are covered under Medicare. Providers, 
carriers, and intermediaries have copies of the Medicare Coverage 
Issues Manual, which identifies those medical items, services, 
technologies, or treatment procedures that can be paid for under 
Medicare. On August 21, 1989, we published a notice in the Federal 
Register (54 FR 34555) that contained all the Medicare coverage 
decisions issued in that manual.
    In that notice, we indicated that revisions to the Coverage Issues 
Manual will be published at least quarterly in the Federal Register. We 
also sometimes issue proposed or final national coverage decision 
changes in separate Federal Register notices. Readers should find this 
an easy way to identify both issuance changes to all our manuals and 
the text of changes to the Coverage Issues Manual.
    Revisions to the Coverage Issues Manual are not published on a 
regular basis but on an as-needed basis. We publish revisions as a 
result of technological changes, medical practice changes, responses to 
inquiries we receive seeking clarifications, or the resolution of 
coverage issues under Medicare. If no Coverage Issues Manual revisions 
were published during a particular quarter, our listing will reflect 
that fact.
    Not all revisions to the Coverage Issues Manual contain major 
changes. As with any instruction, sometimes minor clarifications or 
revisions are made within the text. We have reprinted manual revisions 
as transmitted to manual holders. The new text is shown in italics. We 
will not reprint the table of contents, since the table of contents 
serves primarily as a finding aid for the user of the manual and does 
not identify items as covered or not.

III. How To Use the Addenda

    This notice is organized so that a reader may review the subjects 
of all manual issuances, memoranda, substantive and interpretive 
regulations, or coverage decisions published during the timeframe to 
determine whether any are of particular interest. We expect it to be 
used in concert with previously published notices. Most notably, those 
unfamiliar with a description of our Medicare manuals may wish to 
review Table I of our first three notices (53 FR 21730, 53 FR 36891, 
and 53 FR 50577) and the notice published March 31, 1993 (58 FR 16837), 
and those desiring information on the Medicare Coverage Issues Manual 
may wish to review the August 21, 1989, publication (54 FR 34555).
    To aid the reader, we have organized and divided this current 
listing into five addenda. Addendum I identifies updates that changed 
the Coverage Issues Manual. We published notices in the Federal 
Register that included the text of changes to the Coverage Issues 
Manual. These updates, when added to material from the manual published 
on August 21, 1989, constitute a complete manual as of August 5, 1994. 
Parties interested in obtaining a copy of the manual and revisions 
should follow the instructions in section IV of this notice.
    Addendum II identifies previous Federal Register documents that 
contain a description of all previously published HCFA Medicare and 
Medicaid manuals and memoranda.
    Addendum III of this notice lists, for each of our manuals or 
Program Memoranda, a HCFA transmittal number unique to that instruction 
and its subject matter. A transmittal may consist of a single 
instruction or many. Often it is necessary to use information in a 
transmittal in conjunction with information currently in the manuals.
    Addendum IV lists all substantive and interpretive Medicare and 
Medicaid regulations and general notices published in the Federal 
Register during the quarter covered by this notice. For each item, we 
list the date published, the Federal Register citation, the title of 
the regulation, the Parts of the Code of Federal Regulations (CFR) 
which have changed (if applicable), the agency file code number, the 
ending date of the comment period (if applicable), and the effective 
date (if applicable).
    Addendum V sets forth the revisions to the Medicare Coverage Issues 
Manual that were published during the quarter covered by this notice. 
For the revisions, we give a brief synopsis of the revisions as they 
appear on the transmittal sheet, the manual section number, and the 
title of the section. We present a complete copy of the revised 
material, no matter how minor the revision, and identify the revisions 
by printing in italics the text that was changed. If the transmittal 
includes material unrelated to the revised section, for example, when 
the addition of revised material causes other sections to be 
repaginated, we do not reprint the unrelated material.

IV. How To Obtain Listed Material

A. Manuals

    An individual or organization interested in routinely receiving any 
manual and revisions to it may purchase a subscription to that manual. 
Those wishing to subscribe should contact either the Government 
Printing Office (GPO) or the National Technical Information Service 
(NTIS) at the following addresses:

Superintendent of Documents, Government Printing Office, ATTN: New 
Order, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 783-
3238, Fax number (202) 512-2250 (for credit card orders); or
National Technical Information Service, Department of Commerce, 5825 
Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.

    In addition, individual manual transmittals and Program Memoranda 
listed in this notice can be purchased from NTIS. Interested parties 
should identify the transmittal(s) they want. GPO or NTIS can give 
complete details on how to obtain the publications they sell.

B. Regulations and Notices

    Regulations and notices are published in the daily Federal 
Register. Interested individuals may purchase individual copies or 
subscribe to the Federal Register by contacting the GPO at the address 
indicated above. When ordering individual copies, it is necessary to 
cite either the date of publication or the volume number and page 
number.

C. Rulings

    Rulings are published on an infrequent basis by HCFA. Interested 
individuals can obtain copies from the nearest HCFA Regional Office or 
review them at the nearest regional depository library. We also 
sometimes publish Rulings in the Federal Register.

D. HCFA's Compact Disk-Read Only Memory (CD-ROM)

    HCFA's laws, regulations, and manuals are now available on CD-ROM, 
which may be purchased from GPO or NTIS on a subscription or single 
copy basis. The Superintendent of Documents list ID is HCLRM, and the 
stock number is 717-139-00000-3. The following material is contained on 
the CD-ROM disk:
     Titles XI, XVIII, and XIX of the Act.
     HCFA-related regulations.
     HCFA manuals and monthly revisions.
     HCFA program memoranda.

The titles of the Compilation of the Social Security Laws are current 
as of the January 1, 1993. The remaining portions of CD-ROM are updated 
on a monthly basis.
    The CD-ROM disk does not contain Appendix M (Interpretative 
Guidelines for Hospices). Copies of this appendix may be reviewed at a 
Federal Depository Library (FDL).
    Any cost report forms incorporated in the manuals are included on 
the CD-ROM disk as LOTUS files. LOTUS software is needed to view the 
reports once the files have been copied to a personal computer disk.

V. How To Review Listed Material

    Transmittals or Program Memoranda can be reviewed at a local FDL. 
Under the FDL program, government publications are sent to 
approximately 1400 designated libraries throughout the United States. 
Interested parties may examine the documents at any one of the FDLs. 
Some may have arrangements to transfer material to a local library not 
designated as an FDL. To locate the nearest FDL, individuals should 
contact any library.
    In addition, individuals may contact regional depository libraries, 
which receive and retain at least one copy of most Federal government 
publications, either in printed or microfilm form, for use by the 
general public. These libraries provide reference services and 
interlibrary loans; however, they are not sales outlets. Individuals 
may obtain information about the location of the nearest regional 
depository library from any library.
    Superintendent of Documents numbers for each HCFA publication are 
shown in Addendum III, along with the HCFA publication and transmittal 
numbers. To help FDLs locate the instruction, use the Superintendent of 
Documents number, plus the HCFA transmittal number. For example, to 
find the Carriers Manual, Part 3--Claims Process (HCFA-Pub. 14-3) 
transmittal entitled ``Claims Involving Patients Who Have Elected 
Hospice Care,'' use the Superintendent of Documents No. HE 22.8/7, and 
the HCFA transmittal number 1475.

VI. General Information

    It is possible that an interested party may have a specific 
information need and not be able to determine from the listed 
information whether the issuance or regulation would fulfill that need. 
Consequently, we are providing information contact persons to answer 
general questions concerning these items. Copies are not available 
through the contact persons. Copies can be purchased or reviewed as 
noted above.
    Questions concerning Medicare items in Addenda III may be addressed 
to Margaret Cotton, Issuances Staff, Health Care Financing 
Administration, Room 688 East High Rise, 6325 Security Blvd., 
Baltimore, MD 21207, Telephone (410) 966-5260.
    Questions concerning Medicaid items in Addenda III may be addressed 
to Pat Prete, Medicaid Bureau, Office of Medicaid Policy, Health Care 
Financing Administration, Room 233 East High Rise, 6325 Security Blvd., 
Baltimore, MD 21207, Telephone (410) 966-3246.
    Questions concerning items in Addenda V may be addressed to Walter 
Rutemueller, Office of Coverage and Eligibility Policy, Health Care 
Financing Administration, Room 401 East High Rise, 6325 Security Blvd., 
Baltimore, MD 21207, Telephone (410) 966-5395.
    Questions concerning all other information may be addressed to 
Michael Robinson, Regulations Staff, Health Care Financing 
Administration, Room 132 East High Rise, 6325 Security Blvd., 
Baltimore, MD 21207, Telephone (410) 966-5633.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance, Program No. 93.774, Medicare--
Supplementary Medical Insurance Program, and Program No. 93.714, 
Medical Assistance Program)

    Dated: October 20, 1994.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.

Addendum I

    This addendum lists the publication dates of the quarterly listing 
of program issuances and coverage decision updates to the Coverage 
Issues Manual.

March 20, 1990 (55 FR 10290)
February 6, 1991 (56 FR 4830)
July 5, 1991 (56 FR 30752)
November 22, 1991 (56 FR 58913)
January 22, 1992 (57 FR 2558)
March 16, 1992 (57 FR 9127)
June 11, 1992 (57 FR 24797)
October 16, 1992 (57 FR 47468)
January 7, 1993 (58 FR 3028)
March 31, 1993 (58 FR 16837)
 July 9, 1993 (58 FR 36967)
September 1, 1993 (58 FR 46200)
December 22, 1993 (58 FR 67796)
March 17, 1994 (59 FR 12610)
August 5, 1994 (59 FR 40038)

Addendum II

Description of Manuals, Memoranda, and HCFA Rulings

    An extensive descriptive listing of Medicare manuals and memoranda 
was published on June 9, 1988, at 53 FR 21730 and supplemented on 
September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 
50577. Also, a complete description of the Medicare Coverage Issues 
Manual was published on August 21, 1989, at 54 FR 34555. A brief 
description of the various Medicaid manuals and memoranda that we 
maintain was published on October 16, 1992, at 57 FR 47468.

Program Memorandum for Insurance Commissioners (Non-Manual Issuances)

    This new transmittal is used to convey HCFA's position regarding 
Medigap issues or problems of current interest to State Insurance 
Commissioners. These transmittals are used to communicate information 
or requests for action of a one-time only, non-recurring nature.

        Addendum III.--Medicare and Medicaid Manual Instructions        
                        [April Through June 1994]                       
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 Trans. No.                  Manual/Subject/Publication Number          
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                           Intermediary Manual                          
             Part 1--Fiscal Administration (HCFA-Pub. 13-1)             
              (Superintendent of Documents No. HE 22.8/6-1)             
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125           2O, is defined as the intra-abdominal 
pressure at which leakage occurs from the bladder (around a catheter) 
when the bladder has been filled with a minimum of 150 cc fluid. If the 
patient has an ALLP of less than 65 cm H2O, the diagnosis of ISD 
is established.
    To use a collagen implant, physicians must have urology training in 
the use of a cystoscope and must complete a collagen implant training 
program.
    Coverage of a collagen implant, and the procedure to inject it, is 
limited to the following types of patients with stress urinary 
incontinence due to ISD:
     Male or female patients with congenital sphincter weakness 
secondary to conditions such as myelomeningocele or epispadias;
     Male or female patients with acquired sphincter weakness 
secondary to spinal cord lesions;
     Male patients following trauma, including prostatectomy 
and/or radiation; and
     Female patients without urethral hypermobility and with 
abdominal leak point pressures of 65 cm H2O or less.
    In addition, patients must have shown no improvement in their 
incontinence for at least 12 months prior to collagen therapy. Patients 
whose incontinence does not improve with 5 injection procedures (5 
separate treatment sessions) are considered treatment failures and no 
further treatment of urinary incontinence by collagen implant is 
covered.
    C. Implantable Electronic Stimulators.--Implantable electronic 
stimulators are not covered. (See Sec. 65-11.)
    See Intermediary Manual, Sec. 3110.4.

[FR Doc. 94-28023 Filed 11-10-94; 8:45 am]
BILLING CODE 4120-01-P